[Federal Register Volume 75, Number 165 (Thursday, August 26, 2010)]
[Notices]
[Pages 52601-52605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21243]
[[Page 52601]]
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Part II
Department of Health and Human Services
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Food and Drug Administration
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Food Labeling; Labeling of Food Made From AquAdvantage Salmon; Public
Hearing; Request for Comments; Veterinary Medicine Advisory Committee;
Notice of Meeting; Notices
Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 /
Notices
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0385]
Food Labeling; Labeling of Food Made From AquAdvantage Salmon;
Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing regarding the labeling of food derived from AquAdvantage
Salmon, a genetically engineered Atlantic salmon. The purpose of the
hearing is for FDA to explain the relevant legal principles for food
labeling and to solicit information and views from interested persons
on the application of these principles to the labeling of food derived
from AquAdvantage Salmon. In a separate notice published elsewhere in
this issue of the Federal Register, FDA is announcing that it will hold
a public Veterinary Medicine Advisory Committee (VMAC) meeting.
DATES: See ``How to Participate in the Hearing'' in the SUPPLEMENTARY
INFORMATION section of this document.
ADDRESSES: See ``How to Participate in the Hearing'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT:
For questions about registration, to register orally, or to submit
a notice of participation by mail, fax, or by e-mail: Syreeta Jones, BL
Seamon Corporation, 9001 Edmonston Road, Suite 200, Greenbelt, MD
20770, phone: 301-577-0244 ext. 4900, fax: 301-577-5261, e-mail:
[email protected].
For questions about the hearing, if you need special accommodations
due to a disability, or to submit the full text, comprehensive outline
or summary of an oral presentation: Juanita Yates, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 301-436-1731, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In a separate notice published elsewhere in this issue of the
Federal Register, FDA is announcing that it will hold a public VMAC
meeting. The VMAC will consider issues regarding the safety and
effectiveness of the new animal drug that is the subject of the new
animal drug application (NADA) concerning AquAdvantage Salmon produced
by AquaBounty Technologies, Inc. In the event that the NADA relating to
AquAvantage salmon is approved, public input from this hearing on the
labeling of food from AquAdvantage Salmon will assist FDA in the
application of its food labeling principles which will determine if we
should require labeling for such food beyond that required for food
from other varieties of Atlantic salmon. A background document
entitled, ``Background Document: Public Hearing on the Labeling of Food
Made from the AquAdvantage Salmon'' describing the relevant legal
principles and related questions specific to the labeling of foods from
AquAdvantage Salmon is available at: http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/Topic-SpecificLabelingInformation/default.htm. In addition to this background
document, approximately 2 weeks (but no later than 2 business days)
prior to the hearing, specific technical information on the
AquAdvantage Salmon will be posted on FDA's Web site at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm201810.htm.
The following are five key principles for labeling foods that are
applicable to the specific issue of the labeling of foods from
genetically engineered animals, such as the AquAdvantage Salmon:
1. The law prohibits food labeling that is false (Section 403(a)(1)
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
343(a)(1)));
2. The law prohibits food labeling that is misleading, particularly
in light of material facts about the product (Sections 403(a)(1) and
201(n) of the act (21 U.S.C. 343(a)(1) and 321(n)))\1\;
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\1\ Section 201(n) of the act (21 U.S.C. 321(n) provides
information on how labeling can be misleading. It states that
labeling is misleading if it fails to reveal facts that are (1)
material in light of representations made or suggested in the
labeling, or (2) material with respect to consequences that may
result from the use of the food to which the labeling or advertising
relates under the conditions of use prescribed in the labeling or
under such conditions of use as are customary or usual.
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3. The law allows voluntary labeling about production methods, so
long as the labeling is not false or misleading;
4. The law requires that the label include a name that accurately
describes the basic nature of the food (Section 403(i) of the act (21
U.S.C. 343(i))); and
5. FDA cannot require additional labeling about production methods
unless it is necessary to ensure that the labeling is not false or
misleading (See e.g., 72 FR 16291 at 16294, April 4, 2007). Another way
of stating this point is that FDA cannot require labeling based on
differences in the production process if the resulting products are not
materially different due solely to the production process.
II. Purpose and Scope of the Hearing
The purpose of the hearing is for FDA to explain the relevant legal
principles for food labeling and to solicit information and views from
interested persons on the application of this framework to the labeling
of food derived from AquAdvantage Salmon. The scope of this hearing is
determined by this notice. We invite information and comments on the
issues and questions listed in section III of this document as follows.
III. Issue for Discussion
At this hearing, FDA will seek public comment on the application of
the principles of food labeling to food from the AquAdvantage Salmon.
To facilitate public comment, specific technical information about the
AquAdvantage Salmon will be posted on the FDA website approximately 2
weeks (but no later than 2 business days) prior to the public hearing.
At the public hearing, FDA will be inviting the public to share its
views on:
1. Which facts about the AquAdvantage Salmon seem most pertinent
for FDA's consideration of whether there are any ``material''
differences between foods from this salmon and foods from other
Atlantic salmon. (Keep in mind that the use of genetic engineering does
not, in and of itself, constitute a ``material'' difference under the
law.)
2. If FDA determined there are ``material'' differences, how would
that difference be described on a food label in a way that is truthful
and non-misleading. (Keep in mind that it is the difference in
composition, or in functional, organoleptic or other material
properties that must be described, not the underlying production
process.)
Information about changes in the attributes of the food itself,
such as its nutritional value, functional properties (e.g., storage),
and ``organoleptic'' qualities (e.g., texture and aroma) could be
material (see e.g., 72 FR 16291 at 16293, April 4, 2007). When
commenting on these issues, FDA requests that respondents include
support for their answers with relevant data, where appropriate, and/or
references to the relevant legal principles.
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IV. Notice of Hearing Under 21 CFR Part 15
Because this is the first time the Agency is considering an
application for a genetically engineered animal intended for use as
food, at this hearing FDA invites the public to share its views on the
application of the relevant legal principles of food labeling to food
from the AquAdvantage Salmon. By delegation from the Commissioner of
Food and Drugs (the Commissioner) (Staff Manual Guide 1410.21, section
1(G)(5)), the Assistant Commissioner for Policy finds that because this
is the first time the Agency is considering such an application, it is
in the public interest to permit persons to present information and
views at a public hearing regarding the labeling of food made from
AquAdvantage Salmon, and is announcing that the public hearing will be
held in accordance with part 15 (21 CFR part 15). The presiding officer
will be the Commissioner or her designee. The presiding officer will be
accompanied by a panel of FDA employees with relevant expertise.
Persons who wish to participate in the hearing (either by making an
oral presentation or as a member of the audience) must file a notice of
participation (see Table 1, FOR FURTHER INFORMATION CONTACT, and ``How
to Participate in the Hearing'' in section V of this document). By
delegation from the Commissioner (Staff Manual Guide 1410.21, section
1(G)(5)), the Assistant Commissioner for Policy has determined under
Sec. 15.20(c) that advance submissions of oral presentations are
necessary for the panel to formulate useful questions to be posed at
the hearing under Sec. 15.30(e), and that the submission of a
comprehensive outline or summary is an acceptable alternative to the
submission of the full text of the oral presentation. We request that
individuals and organizations with common interests consolidate their
requests for oral presentations and request time for a joint
presentation through a single representative. After reviewing the
notices of participation and accompanying information, we will schedule
each oral presentation and notify each participant of the time allotted
to the presenter and the approximate time that the presentation is
scheduled to begin. If time permits, we may allow interested persons
who attend the hearing but did not submit a notice of participation in
advance to make an oral presentation at the conclusion of the hearing.
The hearing schedule will be available at the hearing.
After the hearing, we will place the hearing schedule and a list of
participants on file in the Division of Dockets Management (see Table
1) under the docket number listed in brackets in the heading of this
notice.
To ensure timely handling of any mailed notices of participation,
presentations, or comments, any outer envelope should be clearly marked
with the docket number listed in brackets in the heading of this notice
along with the statement ``Food Labeling; Labeling of Food Made From
AquAdvantage Salmon; Public Hearing; Request for Comments.''
Under Sec. 15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to our policy and
procedures for electronic media coverage of our public administrative
proceedings in part 10, subpart C (21 CFR part 10, subpart C). Under
Sec. 10.205, representatives of the electronic media may be permitted,
subject to the procedures and limitations in Sec. 10.206, to
videotape, film, or otherwise record our public administrative
proceedings, including presentations by participants. The hearing will
be transcribed as stipulated in Sec. 15.30(b).
Any persons requiring special accommodations to attend the hearing
due to a disability, should direct those needs to the contact person
(see FOR FURTHER INFORMATION CONTACT).
To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of these provisions as specified in Sec. Sec.
10.19 and 15.30(h). In particular, Sec. 15.21(a) states that the
notice of hearing will provide persons an opportunity to file a written
notice of participation with the Division of Dockets Management within
a specified period of time. If the public interest requires, e.g., if a
hearing is to be conducted within a short period of time, the notice
may name a specific FDA employee and telephone number to whom an oral
notice of participation may be given. If the public interest requires,
the notice may also provide for submitting notices of participation at
the time of the hearing. In this document, the conditions for the
hearing specify that notices of participation be submitted
electronically to an agency Internet site, to a contact person (outside
of FDA) who will accept notices of participation by mail, telephone,
fax, or e-mail, or in person on the day of the hearing (as space
permits). We are using these procedures for submitting notices of
participation, rather than provide for the submission of notices of
participation to the Division of Dockets Management, because the
hearing is to be conducted within a short period of time and these
procedures are more efficient. In addition, these procedures provide
more flexibility to persons who wish to participate in the hearing than
would be provided if participants were required to submit the notice of
participation in writing to the Division of Dockets Management. By
delegation from the Commissioner (Staff Manual Guide 1410.21, section
1(G)(5)), the Assistant Commissioner for Policy finds under Sec. 10.19
that no participant will be prejudiced, the ends of justice will
thereby be served, and the action is in accordance with law if notices
of participation are submitted by the procedures listed in this notice
rather than to the Division of Dockets Management.
V. How to Participate in the Hearing
Advance registration by submission of a notice of participation is
necessary to ensure participation and will be accepted on a first-come,
first-served basis. You may submit the notice of participation
electronically (see Table 1); we encourage you to use this electronic
means of advance registration. You also may submit the notice of
participation orally or by mail, fax, or e-mail (see FOR FURTHER
INFORMATION CONTACT). See Table 1 for the dates by which you must
submit your notice of participation. A single copy of any notice of
participation is sufficient.
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Table 1.--Information on Participation in the Hearing and on Submitting Comments
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Address (Non-
Date Electronic Address electronic) Other Information
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Date of Hearing September 21, ...................... Hilton Hotel and ..........................
2010, from 9 Executive Meeting
a.m. to 4:30 Center, 1750
p.m. Rockville Pike,
Rockville, MD
20850, 301-468-1100
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Advance By September 13, http:// We encourage you to Registration to attend the
Registration 2010 www.fedmeetings.net/ use electronic hearing will also be
common/ registration if accepted onsite on the
registration.cfm?mid= possible. day of the hearing, as
3210 space permits. Requests
made on the day of the
hearing to make an oral
presentation may be
granted as time permits.
Registration information
and information on
requests to make an oral
presentation may be
posted without change to
http://www.regulations.gov,
including any personal
information provided.
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Make a request for By September 8, ...................... .................... ..........................
oral presentation 2010
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Provide a brief By September 13, ...................... Juanita Yates (See Written material
description of the 2010 FOR FURTHER associated with an oral
oral presentation INFORMATION presentation may be
and any written CONTACT) posted without change to
material for the http://
presentation www.regulations.gov,
including any personal
information provided.
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Request special By September 13, ...................... Juanita Yates (See ..........................
accommodations due 2010 FOR FURTHER
to a disability INFORMATION
CONTACT)
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Submit comments By November 22, Federal eRulemaking FAX: 301-827-6870 All comments must include
2010 Portal: http:// Mail/Hand delivery/ the agency name and the
www.regulations.gov. Courier (for paper, docket number found in
Follow the disk, or CD-ROM brackets in the heading
instructions for submissions): of this document. All
submitting comments. Division of Dockets comments received may be
Management (HFA- posted without change to
305), Food and Drug http://
Administration, www.regulations.gov,
5630 Fishers Lane including any personal
rm. 1061, information provided. We
Rockville, MD 20852 encourage you to continue
to submit electronic
comments by using the
Federal eRulemaking
Portal. For additional
information on submitting
comments, see the
``Comments'' heading of
the SUPPLEMENTARY
INFORMATION section of
this document.
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\*\ You may also register or request to make an oral presentation by mail, fax, e-mail, or phone by providing
registration information (including name, title, business affiliation (if applicable), address, telephone
number, fax number (if available), and e-mail address (if available)) (see FOR FURTHER INFORMATION CONTACT).
The notice of participation must include your name, title, business
affiliation (if applicable), address, telephone number, fax number (if
available), and e-mail address (if available). If you wish to request
an opportunity to make an oral presentation during the open public
comment period of the hearing, your notice of participation also must
include the title of your presentation, the sponsor of the oral
presentation (e.g., the organization paying travel expenses or fees),
if any; and the approximate amount of time requested for the
presentation. Presentations must be limited to the questions and
subject matter identified in section III of this document.
Under Sec. 15.20(c), if you request an opportunity to make an oral
presentation you must submit your presentation (either as the full text
of the presentation, or as a comprehensive outline or summary). You may
do so by e-mail or in writing. See Table 1 for the dates by which you
must submit your presentation. See Table 1 and FOR FURTHER INFORMATION
CONTACT for information on where to send your presentation.
Individuals who request an opportunity to make an oral presentation
will be notified of the scheduled time for their presentation prior to
the hearing. Depending on the
[[Page 52605]]
number of oral presentations, we may need to limit the time allotted
for each oral presentation (e.g., 5 minutes each). Depending on the
content of the presentations, the time allotted for oral presentations
may vary. We request that interested persons and groups having similar
interests consolidate their requests for oral presentation and present
them through a single representative. If you need special
accommodations due to a disability, please inform us (see Table 1 and
FOR FURTHER INFORMATION CONTACT).
We will also accept registration onsite; however, space is limited.
Onsite registration will be accepted on a first-come, first-served
basis and will be closed when the maximum seating capacity is reached.
Requests for an opportunity to make a presentation from individuals or
organizations that did not register in advance to make an oral
presentation may be granted if time permits.
Persons who registered in advance for the hearing should check in
at the onsite registration desk between 8:30 and 9 a.m. Persons who
wish to register onsite on the day of the hearing should do so at the
registration desk between 8:30 and 9 a.m. We encourage all participants
to attend the entire day.
VI. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see Table 1) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
VII. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.
Dated: August 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21243 Filed 8-25-10; 8:45 am]
BILLING CODE 4160-01-S